Modafinil for the Treatment of Fatigue in Lung Cancer V9.0
1 other identifier
interventional
208
1 country
24
Brief Summary
Fatigue is a persistent, subjective sense of tiredness, which interferes with a person's usual ability to function. It is believed to be both the most common and the most distressing symptom experienced by those with cancer. Despite the magnitude of the problem, there has been inadequate research into the management of cancer-related fatigue. Central nervous system (CNS) stimulants are the only class of drug established as being directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate (Ritalin), can cause side-effects such as difficulty sleeping at night and anxiety. Modafinil is a relatively new stimulant with few side-effects. There is increasing evidence that modafinil can reduce fatigue in healthy individuals and patients with chronic, non-cancer conditions. No good quality studies have been published evaluating modafinil in patients with cancer, despite multiple calls for such research to be undertaken. The investigators have completed a small study to determine the feasibility of undertaking a larger, high quality study to assess the effect of modafinil on fatigue in patients with lung cancer. Modafinil appeared to improve fatigue rapidly and was not associated with serious side-effects. Ten of the fifteen patients who completed the study chose to continue modafinil long-term. However, the study was too small for definite conclusions to be drawn. This larger, definitive study, funded by a National Cancer Research Institute research award, will establish more clearly whether modafinil can improve fatigue in patients with lung cancer. Two hundred and six patients will be recruited from a number of sites across the UK. Half of the patients will take modafinil, and the other half will take a 'dummy' tablet every day for a month. The fatigue levels of the two groups will be compared. Confirmation that modafinil can relieve cancer-related fatigue could have a highly significant impact on the quality of life of the very large number of patients suffering from this common and distressing symptom.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2009
Typical duration for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 19, 2013
August 1, 2013
3.2 years
January 26, 2009
August 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The fatigue subscale of the Functional Assessment of Chronic Illness Therapy measurement system
28 days
Secondary Outcomes (4)
Epworth Sleepiness Scale
28 days
Hospital Anxiety and Depression Scale
28 days
Quality of life linear analogue scale
28 days
Adverse events
28 days
Study Arms (2)
Treatment group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged 18 years or above
- Diagnosed with NSCLC
- Stage 3a, 3b or stage 4 disease, or recurrent disease after surgery or radiotherapy
- WHO performance status of 0-2
- Participant has a screening score of 5 or more in a 10-point numerical rating scale (NRS) of fatigue severity within two weeks of enrolment
- Able (in the investigator's opinion) and willing to comply with all study requirements, including ability to participate for in study for 28 days
- Willing to allow his or her General Practitioner to be notified of participation in the study.
You may not qualify if:
- Received radiotherapy or chemotherapy within the last 4 weeks
- Commenced on an EGFR tyrosine kinase inhibitors eg Gefitinib and Erlotinib within the last 6 weeks.
- Commenced on antidepressants or steroids (corticosteroids and progestational steroids) within the last 2 weeks
- Received blood transfusion within the last 2 weeks
- Potentially fertile woman of child-bearing age
- Major anxiety requiring intervention in secondary care
- History of arrhythmia requiring medical intervention
- Uncontrolled hypertension with blood pressure greater than 160/100 mmHg
- History of cor pulmonale or left ventricular hypertrophy
- Currently taking warfarin
- Previous adverse reaction to modafinil or other CNS stimulant
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or affect the participant's ability to participate in the study
- Currently participating in another research study involving an investigational product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Stoke Mandeville Hospital
Aylesbury, United Kingdom
Macclesfield District Hospital
Cheshire, United Kingdom
University Hospital of North Tees
County Durham, United Kingdom
Basildon and Thurrock University Hospitals
Essex, United Kingdom
Basingstoke and North Hampshire Hospital
Hampshire, United Kingdom
East Kent University Hospitals
Kent, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, United Kingdom
University Hospital
Llandough, United Kingdom
Royal Marsden Hospital Fulham Road
London, United Kingdom
Royal Marsden Hospital Sutton
London, United Kingdom
St George's Hospital
London, United Kingdom
Christie Hospital
Manchester, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Harrogate and District NHS Foundation Trust
North Yorks, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Papworth Hospital
Papworth Everard, United Kingdom
Withybush General Hospital
Pembrokeshire, United Kingdom
Peterborough District Hospital
Peterborough, United Kingdom
Royal Surrey County Hospital
Surrey, United Kingdom
Great Western Hospital
Swindon, United Kingdom
Hillingdon Hospital
Uxbridge, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
West Yorkshire, United Kingdom
Mid Yorkshire Hospital NHS Trust
West Yorkshire, United Kingdom
Related Publications (1)
Spathis A, Fife K, Blackhall F, Dutton S, Bahadori R, Wharton R, O'Brien M, Stone P, Benepal T, Bates N, Wee B. Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. J Clin Oncol. 2014 Jun 20;32(18):1882-8. doi: 10.1200/JCO.2013.54.4346. Epub 2014 Apr 28.
PMID: 24778393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bee Wee, PhD
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2009
First Posted
January 27, 2009
Study Start
February 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 19, 2013
Record last verified: 2013-08